Overview

Comparison of CornerLoc SI Joint Stabilization and Steroid Injections for Sacroiliac Joint Dysfunction

Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
Summary
This study has been designed to compare the safety and effectiveness of the CornerLoc™ SI Joint Stabilization System to intra-articular sacroiliac joint steroid injection in patients with refractory sacroiliac joint dysfunction.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CornerLoc
Criteria
Inclusion Criteria:

- Subjects meeting all of the following inclusion criteria by the end of the screening
phase should be considered for admission to the study:

- Subject must provide written informed consent prior to any clinical study-related
procedure.

- Subject is at least 18 years (or the minimum age required by local law to consent
for participation in a clinical investigation) or older at the time of
enrollment.

- Subjects must meet criteria for sacroiliac joint dysfunction as determined below:

- History of persistent pain in the distribution of the sacroiliac joint despite
adequate trial of physical therapy.

- NRS for pain ≥ 7 on a 0 -.10-point scale.

- 3 of 5 provocative tests with positive findings on physical examination (SI
distraction, thigh thrust, FABER, lateral compression, Gaenslen's maneuver).

- Positive response (≥75% percent pain relief) to diagnostic sacroiliac joint
injection on two occasions at least one week apart.

- Baseline pain with 30-day history and PROMIS-29

Exclusion Criteria:

- Patient will not be entered into the study if they meet one of the following criteria:

- Subject is unable to provide written informed consent

- Subject is enrolled, or intends to participate, in a clinical drug and/or device
study (investigational device, investigational drug, new indication for a device
or drug, or additional testing beyond standard of care procedures) which could
confound the results of this trial as determined by the investigator.

- Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the clinical investigation or to comply with
follow-up requirements, or impact the scientific soundness of the clinical
investigation results.

- Subject had prior surgical fusion implanted on same side

- Subject is pregnant or nursing

- Self-reported plan to bear children

- BMI ≥ 40

- DEXA < -2.5 (if available)

- History of microfractures

- History of compression fractures

- History of diabetes, must have A1c <8

- History of chronic steroid use

- Chronic immunosuppression